The manufacturer has to decide how to classify the reagent, not the user.

Tim Morken, B.A., EMT(MSA), HTL(ASCP)
Infectious Disease Pathology
Centers for Disease Control
MS-G32
1600 Clifton Rd.
Atlanta, GA 30333
USA

email: tim9@cdc.gov
       timcdc@hotmail.com

Phone: (404) 639-3964
FAX:  (404)639-3043


----Original Message Follows----
From: "Goodwin, Diana" <DGoodwin@CHSNJ.org>
To: "'Histonet'" <HistoNet@pathology.swmed.edu>
Subject: FDA Final Rule
Date: Wed, 22 Sep 1999 09:52:53 -0400

Good Morning , Histonet.

After reading Debbie Jennings-Sienna's article in the latest edition of
NSH in Action, I am still confused as to the classification of
commercially available primary antibodies.  Are they or are they not
considered to be ASR's?  Are we or are we not, as a clinical laboratory,
required to include a disclaimer on reports to clinicians of patients on
whom our lab has performed IHC testing using commercially available
primary antibodies?

Diana Goodwin,  HT
Trenton,  NJ







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